Technology | September 11, 2012

Abiomed Receives FDA Clearance For Higher Flow Impella Heart Pump

New VAD offers peak flows of 4 liters per minute without need for surgical cut-down

Abiomed Impella CP VAD

September 11, 2012 -- Abiomed Inc. announced it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for a new percutaneous, catheter-based Impella ventricular assist device (VAD) providing peak flows of approximately 4 liters of blood per minute. The increased flow is delivered on the same console platform, 9 French catheter and introducer as the Impella 2.5. This new heart pump will be marketed as the Impella CP (Cardiac Power) within the United States and has been commercially known outside the U.S. as the Impella cVAD.

“The clinical community has been anxiously anticipating the arrival of this new Impella pump. The Impella CP promises a substantial amount of cardiac power, can be inserted quickly, and is ideal for patients that require more hemodynamic support,” said John Lasala M.D., medical director of Washington University School of Medicine in St. Louis. “It is exciting for physicians to be able to provide this type of percutaneous support that represents approximately 80 percent of what a healthy heart can pump each minute.”   

This 510(k) clearance designates that the Impella CP has the same indications for use as the Impella 2.5 and includes a limitation in the Impella CP instructions for use (IFU). In April 2012, Abiomed received CE marking approval to market the Impella cVAD in the European Union. Abiomed plans to have a controlled launch with top heart hospitals in the United States, with full U.S. commercial availability of the Impella CP expected by the fourth quarter of fiscal 2013. 

Abiomed has three FDA studies (PROTECT I, RECOVER I, PROTECT II) that are now published on Impella, and there are also over 150 peer reviewed publications including real world usage data from the Europe and U.S. Impella registries. Additionally, Impella has been utilized to support over 10,000 U.S. patients, has been incorporated into the medical guidelines and has recently been approved for a dedicated CPT code for physician payment.

For more information: www.abiomed.com

 

Related Content

Medtronic Receives FDA Approval for Less-Invasive Heart Pump Implant Procedure
Technology | Ventricular Assist Devices (VAD) | July 17, 2018
Medtronic plc recently received U.S. Food and Drug Administration (FDA) approval for a less-invasive implant approach...
CorWave's Next-generation Neptune LVAD Receives Funding

Image courtesy of CorWave

News | Ventricular Assist Devices (VAD) | July 11, 2018
French-based CorWave announced that its CALYPSO program has received 14 million euros to develop CorWave Neptune, a new...
Abbott Recalls the HeartMate 3 Left Ventricular Assist System, LVAD
News | Ventricular Assist Devices (VAD) | May 23, 2018
Abbott has initiated a Class I recall of the HeartMate 3 Left Ventricular Assist System due to a malfunction in the...
FDA Approves Abiomed Impella CP With SmartAssist and Optical Sensor
Technology | Ventricular Assist Devices (VAD) | April 02, 2018
Abiomed Inc. announced that it received U.S. Food and Drug Administration (FDA) Pre-Market Approval (PMA) for its...
Reduced Device Clotting, Decreased Strokes Seen With HeartMate 3 at Two Years
News | Ventricular Assist Devices (VAD) | March 13, 2018
At two years of follow-up, severely ill patients with advanced heart failure who received a novel heart pump fully...
Medtronic HeartWare HVAD System Approved for Destination Therapy
Technology | Ventricular Assist Devices (VAD) | October 04, 2017
October 4, 2017 — Medtronic received U.S.
Abiomed Receives FDA PMA Approval for Impella RP for Right Heart Failure
Technology | Ventricular Assist Devices (VAD) | September 28, 2017
Abiomed Inc. recently received U.S. Food and Drug Administration (FDA) pre-market approval (PMA) for the Impella RP ...
Abbott Receives FDA Approval for HeartMate 3 Left Ventricular Assist System
Technology | Ventricular Assist Devices (VAD) | August 29, 2017
Abbott announced it has received U.S. Food and Drug Administration (FDA) approval for its Full MagLev HeartMate 3 Left...
Pre-PCI Impella 2.5 Insertion Improves Survival in Left Main Coronary Artery Heart Attacks
News | Ventricular Assist Devices (VAD) | June 30, 2017
Abiomed Inc. announced the recent publication of a peer-reviewed retrospective study on hemodynamic support with the...
Overlay Init